Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:53 PM
Study NCT ID:
NCT07465458
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiofrequency Ablation Multicenter Observational Study in Renal Oncology Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 226}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2026-03-06', 'studyFirstSubmitQcDate': '2026-03-06', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical success', 'timeFrame': 'up to 2 months post-procedure', 'description': 'ablation zone evaluated post-ablation'}, {'measure': 'Technical efficacy', 'timeFrame': 'up to 12 months', 'description': 'Abscence of tumor recurrence within the margin of the ablation zone or viable residual tumor on follow-up imaging'}], 'secondaryOutcomes': [{'measure': 'Ablation related complications', 'timeFrame': 'up to 12 months', 'description': 'complications and adverse events'}, {'measure': 'TRIFECA achievement', 'timeFrame': 'up to 12 months', 'description': 'Evaluate RFA procedural success based on the TRIFECA benchmark standards'}, {'measure': 'Treatment efficacy by tumor histotypes', 'timeFrame': 'up to 12 months', 'description': 'RFA outcome according to histological subtype'}, {'measure': 'Local Tumor Progression (LTP)', 'timeFrame': 'up to 12 months', 'description': 'evaluate the number of patients who develop local recurrence or residual tumor growth after ablation'}, {'measure': 'Distant metastasis-free survival (DMFS)', 'timeFrame': 'up to 12 months', 'description': 'evaluate the number of patients who develop distant metastasis after ablation'}, {'measure': 'Overall Survival', 'timeFrame': 'up to 12 months', 'description': 'Time from RFA to death for any cause'}, {'measure': 'Cancer Specific Survival (CSS)', 'timeFrame': 'up to 12 months', 'description': 'Time from RFA to renal cell carcinoma (RCC)-related death'}, {'measure': 'Preserved renal function', 'timeFrame': 'up to 12 months', 'description': 'evaluate the impact of RFA on renal function'}, {'measure': 'Retreatment rate', 'timeFrame': 'up to 12 months', 'description': 'number of participants requiring additional RFA'}, {'measure': 'Time to local tumor progression ( TT-LPP)', 'timeFrame': 'up to 12 months', 'description': 'time in months from initial RFA to first detection of local tumor on imaging'}, {'measure': 'Patient reported outcomes', 'timeFrame': 'up to 12 months', 'description': 'Pain and quality of life questionaires (QOL) - European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (higher score worst outcome'}, {'measure': 'Cost-effectiveness analysis', 'timeFrame': 'up to 12 months', 'description': 'compare the cost of RFA versus partial nephrectomy in terms of hospitalization days, post-treatment patient management, and retreatment rates.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Carcinoma']}, 'descriptionModule': {'briefSummary': 'This observational study is designed to expand the current database available in the literature and the existing knowledge on the outcomes and safety of radiofrequency ablation (RFA) for the treatment of primary renal cell carcinomas in stage T1a. All interventions and subsequent follow-ups are clinical decisions are independent of the study, given its observational nature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with primary renal cell carcinomas in stage T1a', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patient selection criteria will be those typically established by each participating center t with T1a primary renal tumors for which a Multidisciplinary Tumor Board has indicated as candidates for treatment with radiofrequency ablation.I\n\nInclusion Criteria:\n\n* Age ≥18 years\n* Signed informed consent approved by the Ethics Committee prior to the ablation procedure.\n* RCC in stage T1a (size \\<4 cm), single or multiple, histologically demonstrated by percutaneous biopsy before or within 30 days prior to ablation\n* Absence of comorbidities that contraindicate treatment\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2 at baseline screening.\n\nExclusion Criteria:\n\n* No specific exclusion criteria are established for this clinical registry due to its observational nature. Each center will apply its own criteria according to its routine clinical practice.'}, 'identificationModule': {'nctId': 'NCT07465458', 'acronym': 'RASROP-003', 'briefTitle': 'Radiofrequency Ablation Multicenter Observational Study in Renal Oncology Patients', 'organization': {'class': 'OTHER', 'fullName': 'Humanitas Hospital, Italy'}, 'officialTitle': 'Radiofrequency Ablation Multicenter Observational Study in Renal Oncology Patients', 'orgStudyIdInfo': {'id': 'RASROP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Radiofrequency Ablation (RFA)', 'type': 'DEVICE', 'otherNames': ['Next-generation Radiofrequency Generator (Cambridge Interventional)'], 'description': 'Minimally invasive RFA in T1a renal carcinomas'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'state': 'Milano', 'country': 'Italy', 'facility': 'IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Brescia', 'country': 'Italy', 'contacts': [{'name': 'Claudio Salemi, MD', 'role': 'CONTACT'}, {'name': 'Claudio Salemi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondazione Poliambulanza Istituto Ospedaliero', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Milan', 'country': 'Italy', 'contacts': [{'name': 'Franco Orsi, MD', 'role': 'CONTACT', 'phone': '+39 0257489060'}, {'name': 'Franco Orsi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituto Europeo di Onclologia ( IEO)', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Roma', 'country': 'Italy', 'contacts': [{'name': 'Francesco Grasso, MD', 'role': 'CONTACT'}, {'name': 'Francesco Grasso, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Policlinico Universitario Campus Bio-Medico', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Barcelona', 'country': 'Spain', 'contacts': [{'name': 'Xavier Serres, MD', 'role': 'CONTACT'}, {'name': 'Xavier Serres, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clínico Universitario', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Córdoba', 'country': 'Spain', 'contacts': [{'name': 'Juan Jose Espejo Herrero, MD', 'role': 'CONTACT'}, {'name': 'Juan Jose Espejo Herrero, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Reina Sofía', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'city': 'Madrid', 'country': 'Spain', 'contacts': [{'name': 'Jose Maria Abadal, MD', 'role': 'CONTACT'}, {'name': 'Jose Maria Abadal, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario de Leganés (Severo Ochoa)', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'contacts': [{'name': 'Eduardo Crespo, MD', 'role': 'CONTACT'}, {'name': 'Eduardo Crespo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Fundación Jiménez Díaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'contacts': [{'name': 'Santiago Mendez Alonso, MD', 'role': 'CONTACT'}, {'name': 'Santiago Mendez Alonso, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Puerta de Hierro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'San Sebastián', 'country': 'Spain', 'contacts': [{'name': 'Jose Luis Del Cura, MD', 'role': 'CONTACT'}, {'name': 'Jose Luis Del Cura, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Donostia', 'geoPoint': {'lat': 43.56667, 'lon': -5.9}}], 'centralContacts': [{'name': 'Vittorio Pedicini, MD', 'role': 'CONTACT', 'email': 'vittorio.pedicini@humanitas.it', 'phone': '+39335539641'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Humanitas Hospital, Italy', 'class': 'OTHER'}, 'collaborators': [{'name': 'SACMI-Sociedad Aragonesa de Cirugìa Minimamante Invasiva', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Vittorio Pedicini', 'investigatorAffiliation': 'Humanitas Hospital, Italy'}}}}